Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis

Part of paid clinical trials in San Francisco, California.

Sponsor
University of Minnesota
Study ID
NCT03587831
Status
Recruiting
Apply to this trial

Conditions

  • NASH - Nonalcoholic Steatohepatitis

Eligibility Criteria

Sex
ALL
Age
30 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Vertical Sleeve Gastrectomy — PROCEDURE
    Surgical Procedure: Vertical Sleeve Gastrectomy
  • Lifestyle Modification Counseling — BEHAVIORAL
    Behavioral Intervention: Lifestyle Modification Counseling

Study Details

Participants meeting study entry criteria are randomized with equal probability to one of two study groups: (1) Lifestyle modification or (2) Vertical Sleeve Gastrectomy (VSG) with Iifestyle modification, followed for 12 months. The primary goal for the trial is to determine if the investigators can recruit, randomize, and retain participants to perform invasive and non-invasive measurements of NASH and fibrosis, deliver lifestyle modification and demonstrate the safety of VSG. The investigators wish to also understand which of these two interventions is more effective in achieving, 12 months after entry into the trial, a reduction in NAS composed of the non-weighted scores: (1) steatosis 0-3 (2) Inflammation 0-3 and (3) ballooning 0-2. Secondary goals include comparing the two treatment groups for changes in other measured outcomes including MRI assessments of intrahepatic triglyceride and liver elasticity and serum markers. As a pilot study, a sample size of 20 in each group should offer significant information as to the difference in NAS score reduction between to two groups and achieve adequate power to distinguish clinically significant changes in the primary and secondary outcome measures. These data support the overarching objective i.e. to provide evidence that a larger, longer-term clinical outcomes trial is feasible. A goal is for a longer term follow up for 5 years to assess the durability of treatment effects and treatment differences.

Key Dates

Start date
Jul 1, 2021
Status verified
May 2026
Primary completion
Sep 15, 2026
Completion
Sep 15, 2026

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: VSG + LSM
    Procedure/Surgery: Vertical Sleeve Gastrectomy will be performed using five laparoscopic ports. The short gastric and epiploic vessels will be taken down With a 40 French Bougie in place, the greater curvature will be excised starting 6 cm proximal to the pylorus. Behavioral: Lifestyle Modification Counseling - The intensive lifestyle intervention will align with methods listed in the LSM arm description. However, participants assigned to the VSG will not have calorie ceilings during the first 6 months of rapid weight loss, and they will receive additional instruction regarding food volume and adequate protein intake.
  • Active Comparator: LSM
    Behavioral: Lifestyle Modification Counseling - The intensive lifestyle intervention is modeled after the LookAHEAD trial, with modules modified for participants undergoing surgery, and designed to produce maximum achievable weight loss. Both groups will increase their level of moderate-intensity physical activity (such as walking) to a total of 325 minutes per week. All lifestyle-medical management participants will be given calorie intake targets of 1200, 1500, or 1800 kilocalories per day, depending on body weight, with the goal of producing a weight loss of 1 to 2 pounds per week. There will be 24 weekly counseling meetings during the first 6 months, bi-weekly meetings between months 7 and 9, and monthly meetings between months 10 and 12.

Primary Outcome Measure

Histologic improvements in NAFLD Activity Score (NAS) [ Time Frame: Month 12 ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of San FransiscoSan FranciscoCalifornia94143
Bilal Hameed, MD
[email protected]
Andrew Posselt, MD, PhD
[email protected]
Bilal Hameed, MD (PRINCIPAL_INVESTIGATOR)
Andrew Posselt (SUB_INVESTIGATOR)
Pennington Biomedical Research CenterBaton RougeLouisiana70808
Philip Schauer
[email protected]
225-763-3122
Vance Albaugh
[email protected]
225-763-2772
Minneapolis VA Medical CenterMinneapolisMinnesota55417
Sayeed Ikramuddin
[email protected]
612-313-3246
Charles Billington
[email protected]
612-467-3012
University of MinnesotaMinneapolisMinnesota55455
Shannon Jannatpour
[email protected]
612-624-5746
Sayeed Ikramuddin, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of San Fransisco· San Francisco, CAPennington Biomedical Research Center· Baton Rouge, LAMinneapolis VA Medical Center· Minneapolis, MNUniversity of Minnesota· Minneapolis, MN

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